{"id":4058,"date":"2026-02-25T08:25:44","date_gmt":"2026-02-25T07:25:44","guid":{"rendered":"https:\/\/iph-multisite.berta-bewegt.ch\/?page_id=4058"},"modified":"2026-02-25T08:25:44","modified_gmt":"2026-02-25T07:25:44","slug":"praeklinische-phase","status":"publish","type":"page","link":"https:\/\/www.interpharma.ch\/en\/themen\/fuhrend-in-forschung-entwicklung\/der-weg-eines-medikaments\/praeklinische-phase\/","title":{"rendered":"The preclinical phase"},"content":{"rendered":"\n<p>An\nactive substance candidate has to undergo a preclinical development programme\nbefore it can be administered to humans in clinical trials. In this programme,\nthe substance is tested for possible harmful effects, such as whether it is\ntoxic, causes cancer or modifies the genetic material. These tests are\nperformed first in cell cultures and then in animal studies. <\/p>\n\n\n\n<p>It\nmay not be tested in humans until it has passed all the required preclinical\ntests. The tests in cell cultures and animals that document its harmlessness\nare performed in accordance with internationally accepted guidelines (ICH\nguidelines) which in turn are based on the 3R principles of Replace, Reduce and\nRefine. <\/p>\n\n\n\n<p>The\npreclinical phase comprises the following studies:<\/p>\n\n\n\n<ul class=\"post wp-block-list\"><li>pharmacological studies,<\/li><li>general toxicity studies,<\/li><li>toxicokinetic and pharmacokinetic studies <strong>and<\/strong><\/li><li>multiple-dose toxicity studies.<\/li><\/ul>\n\n\n\n<p>Other\npreclinical studies are carried out in some cases depending on the specific\nconditions. These include an assessment of phototoxicity (when a skin response\nis triggered by exposure to light).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>An active substance candidate has to undergo a preclinical development programme before it can be administered to humans in clinical trials. In this programme, the substance is tested for possible harmful effects, such as whether it is toxic, causes cancer or modifies the genetic material. These tests are performed first in cell cultures and then [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4288,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4058","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>The preclinical phase - Interpharma<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interpharma.ch\/en\/themen\/fuhrend-in-forschung-entwicklung\/der-weg-eines-medikaments\/praeklinische-phase\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The preclinical phase\" \/>\n<meta property=\"og:description\" content=\"An active substance candidate has to undergo a preclinical development programme before it can be administered to humans in clinical trials. 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